Led · Series A · Feb 2020

Lumos Diagnostics develops and manufactures rapid point-of-care diagnostic tests and digital reader platforms, with proprietary products including the 10-minute FebriDx fingerstick test and the COV-ID serology kit. The company sells CE-marked tests and has registrations or licenses with Health Canada, Australia TGA, and several other health authorities; FebriDx is not yet commercially available in the U.S. Lumos also provides customized assay development and manufacturing services and secured contracts to develop and manufacture next-generation rapid SARS-CoV-2 tests. The company has ongoing and historic prospective, multicenter U.S. clinical trials for FebriDx and anticipates U.S. FDA clearance. Recent growth has come across both its service and product businesses during the COVID-19 pandemic, and the company is piloting FebriDx in aged care and other professional settings. The recent capital raise is intended to support U.S. commercial expansion and manufacturing scale-up. Lumos Diagnostics, based in Sarasota, Fla., develops rapid point-of-care diagnostic test solutions built around its FebriDx test and a proprietary digital reader platform. FebriDx is a single-use, fingerstick test that assesses the host immune response to acute respiratory infection by detecting MxA and CRP, delivering results in about 10 minutes. The company positions FebriDx to help clinicians differentiate viral and bacterial ARIs and reports a 97–99% negative predictive value for ruling out bacterial infection to reduce unnecessary antibiotic prescriptions. Lumos also offers assay development and manufacturing services for customized POC tests and plans to commercialize a suite of Lumos-branded tests targeting infectious and inflammatory diseases using host-response biomarkers. The recently announced funding will support international commercial expansion, a U.S. FDA pivotal clinical trial for FebriDx, and additional development and manufacturing resources for its expanding full-service POC business. FebriDx holds Health Canada approval, Saudi Arabia FDA clearance, Singapore HSA registration, Pakistan DRAP registration, and a CE mark for Europe, but it has not yet received U.S. FDA clearance or commercial availability in the United States.